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临床试验/NCT04675177
NCT04675177已完成2 期

Sclerotherapy With Polidocanol Foam Versus Hemorrhoidal Artery Ligation With Recto Anal Repair in the Treatment of Second and Third-grade Hemorrhoidal Disease: a Prospective Study

Universidade do Porto1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2019年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
45
试验地点
1
主要终点
Therapeutic success

研究概览

简要总结

Background: Hemorrhoidal disease is extremely frequent in the adult population and, as a benign pathology, the treatment should be guided by the patient's symptoms. Treatment of hemorrhoidal disease includes a conservative approach, office-based treatments and surgery.

This study is aimed to evaluate and compare the efficacy and safety of the treatment of hemorrhoidal disease with non-surgical office-based method polidocanol foam sclerotherapy (SP) and the surgical technique doppler-guided hemorrhoidal artery ligation with recto-anal repair.

Methods: Prospective, unicentric study including patients with symptomatic hemorrhoidal disease grade II and III refractory to conservative therapy, submitted either to SP (n=24) or to HAL-RAR procedure (n=21), during a recruitment period of 6 months.

Patients were evaluated for efficacy (Sodergren's scale of symptoms and severity of bleeding) and safety (complications and implication in personal and professional life), up to one month after treatment. In follow-up period (6 months) participants were evaluated for hemorrhoidal disease recurrence.

详细描述

INTRODUCTION:

Instrumental office-based procedures are usually indicated for internal hemorrhoidal disease grade I and II which are refractory to conservative medical treatments and in selected cases of grade III hemorrhoidal disease. Despite being invasive, these techniques are more conservative than surgical treatments and are also effective. The primary goals are to decrease the amount of redundant tissue, reduce vascularity, and affix the hemorrhoidal cushions to minimize prolapse. Office-based procedures include rubber band ligation (RBL), sclerotherapy (liquid and foam agents), infrared photocoagulation, cryotherapy, radiofrequency ablation among others.

Hemorrhoidal sclerosis is a procedure indicated to treat grade I and II hemorrhoidal disease. It has also been used in the treatment of internal grade III hemorrhoidal disease, but there are limited data on its efficacy. Performed through an anoscope and according to Blanchard technique, internal hemorrhoids are located and injected with a sclerosant material into the submucosa at the base of the hemorrhoid, above the anterolateral line. The sclerosant subsequently causes an inflammatory response and fibrosis that interrupts the vascular blood supply. A variety of sclerosants have been used including ethanolamine, quinine, hypertonic saline, aluminum potassium sulfate and tannic acid (ALTA), and 5% phenol in oil. Recently, a new sclerosing agent, polidocanol, started to be employed in the treatment of hemorrhoidal disease. It is a nonionic detergent and consists of a hydrophilic polyethylene oxide chain combined with hydrophobic aliphatic dodecyl alcohol. When injected into varicose veins, polidocanol damages the endothelium of blood vessels, allowing platelets to aggregate. Eventually, a dense network of platelets, cellular debris, and fibrin occludes the vessel, which is subsequently replaced with connective fibrous tissue. In addition to the treatment of hemorrhoidal disease, polidocanol is used for sclerotherapy of varicose veins of the lower extremities and for the treatment of esophageal varices. The advantages of this sclerosing agent include a highly satisfactory efficiency, a low necrotic potential, and a good general tolerance. At the same time, it has a local anesthetic effect which permits almost painless sclerotherapy. Nevertheless, its use is contraindicated in patients with acute thromboembolic diseases and in those with allergy to the drug. Polidocanol can be used in its liquid or foam form. It has been proved the foam formulation allows for greater efficacy, since it requires lower doses of sclerosant agent. This is because the sclerotic effect is maximized by increasing the contact surface area with varices walls. This foam is previously prepared according to the Tessari's method, in which two 10 mL syringes are connected by a 3-way stopcock. The syringes contain air and a sclerosing agent (3% polydocanol), with a ratio of 4:1, respectively, and twenty passages from one syringe to the other are made in order to obtain a sclerosing foam. Several studies reported the efficacy of the use of sclerotherapy with liquid polidocanol in hemorrhoidal disease. Specifically for the treatment of grade I hemorrhoids, there is one study showing the superiority of polidocanol foam compared to its liquid formulation. However, there's a lack of research about its use in hemorrhoidal disease other than grade I. The most common complications of sclerotherapy include minor discomfort or bleeding. Although it is a very safe treatment option, some serious side effects, including erectile dysfunction and urinary retention, have been reported. The proper injection technique of sclerosant is essential to avoid complications such as mucosal ulceration or necrosis, prostatic abscess and retroperitoneal sepsis. Sclerotherapy is a valid alternative when conservative therapy has failed. Moreover, this procedure can also be used for the treatment of patients whose hemorrhage is the main symptom, for patients on antithrombotic medication, as well as cirrhotic and immunocompromised patients.

Surgical treatment is reserved for refractory cases to nonsurgical approaches, grade IV or mixed hemorrhoidal disease (internal and external components), symptomatic hemorrhoidal disease with concomitant anorectal pathology and lastly if it's the patient's choice. Although surgical approach is apparently more effective than instrumental treatment, it is also associated with substantial postsurgical morbidity, particularly postoperative pain and limitation in day-life activities. Several surgical methods have been described including open and closed hemorrhoidectomy, doppler guided hemorrhoidal artery ligation (HAL) and hemorrhoidectomy stapler. The choice of each method should consider the grade of hemorrhoidal disease and the predominant symptoms of the patient, together with the experience of the center.

HAL technique involves the use of Doppler ultrasound and a specialized anoscope. The principles include the use of a Doppler probe to identify the six main feeding arteries within the anal canal and their ligation with absorbable suture above the dentate line, therefore associated with less pain. Finally, plication of redundant hemorrhoidal mucosa is performed (if there is hemorrhoidal or muco-hemorrhoidal prolapse), known as recto-anal-repair (RAR), mucopexy or hemorrhoidopexy. The aim of this recent surgical procedure is to treat patients' symptoms without tissue destruction. Early results of HAL were promising, with lower pain scores than hemorrhoidectomy, and relief of bleeding and tissue prolapse in over 90% of patients. Since then, several randomized clinical trials have been performed with mixed results. Currently, HAL remains a viable approach to multicolumn internal hemorrhoids. However, the short-term benefits regarding postoperative pain have recently not been as remarkable as in the earlier studies. Also, there has been a progressive increase in long term recurrence rates, especially for grade III and IV hemorrhoids.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients older than 18 years with symptomatic hemorrhoidal disease grade II and III (Goligher's classification)
  • Refractory to conservative therapy (dietary modification, intestinal transit modifiers, topical and phlebotonic medications) for a period of not less than 4 weeks

排除标准

  • Cirrhosis
  • Pregnant or breast-feeding women
  • Known allergy to polidocanol
  • Another perianal disease that can cause symptoms similar to hemorrhoidal disease
  • Colorectal malignancy
  • Concomitant presence of external hemorrhoidal disease and/or hemorrhoidal thrombosis - - Office or surgical treatment for hemorrhoids within 6 months prior to inclusion
  • Antiplatelet or hypocoagulant medication
  • Hematological disorders
  • Immunosuppressive states
  • Inflammatory bowel disease
  • Patients unable to have general or spinal anesthetic

研究组 & 干预措施

Polidocanol foam sclerotherapy

Active Comparator

Patients submitted to polidocanol foam sclerotherapy

干预措施: Polidocanol foam sclerotherapy (Drug)

Doppler-guided hemorrhoidal artery ligation

Active Comparator

Patients submitted to doppler-guided hemorrhoidal artery ligation

干预措施: Doppler-guided hemorrhoidal artery ligation (Procedure)

结局指标

主要结局

Therapeutic success

时间窗: 3 months

Efficacy indicator composed by Sodergren score and bleeding grade: * Complete (Sodergren score = 0 and bleeding grade \<= 1); * Partial (Sodergren score \> 0 and bleeding grade \> 1 but, at least, one of them with improvement, regarding the initial score, and none of them worse); * Therapeutic failure (participants that, one month after the last instrumental treatment or one month after surgery, worsened or maintained the initial Sodergren score and bleeding grade);

Safety evaluation

时间窗: 3 Months

Record of complications resulting from the therapy: * Mild (e.g. pain/discomfort, pruritus, bleeding grade 1) * Moderate (e.g., external hemorrhoidal thrombosis, bleeding without hemodynamic instability, no blood transfusion, no need for haemostasis or urgent surgery): do not endanger the patient's life or leave long term sequelae; * Severe (e.g. sepsis, Fournier's gangrene, perineal abscess, bleeding with hemodynamic instability, transfusional need or urgent surgery, sexual impotence in man): they put the patient's life at risk.

次要结局

  • Professional life implications(3 months)
  • Personal life implications(3 months)
  • Number of treatment sessions(3 months)
  • Recurrence(6 Months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paulo Sérgio Durão Salgueiro

Principal Investigator

Universidade do Porto

研究点 (1)

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